Systems and method for delivering pulsed electric current to living tissue

ABSTRACT

A patient treatment unit for delivering non-invasive pulsed energy to living tissue with a probe stimulus generator circuit configured to output, as a treatment signal, a sequence of DC electrical pulses at a controlled pulse frequency of about 20 kHz and having a pulse voltage defined by a variable supply voltage of the probe stimulus generator circuit. The unit includes primary and secondary probes for contacting a body, an intensity adjustment circuit configured to control the variable supply voltage, and an electronic timer display configured to display an elapsed time in decimal numbers in minute and second format. An electrical current of the pulses is in a range of 0.1-2 mA while the probes are contacting the body. An operating output voltage across the probes while conducting the treatment signal does not exceed a maximum operating output voltage of 165 VDC while the probes are contacting the body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Application No.PCT/US20/37625, filed Jun. 12, 2020, which claims priority under 35U.S.C. § 119 to and the benefit of U.S. Provisional Patent ApplicationSer. No. 62/860,678, filed on Jun. 12, 2019, and titled “System AndMethod For Delivering Pulsed Electric Current To Living Tissue,” both ofwhich is incorporated herein by reference in their entireties.

FIELD OF THE INVENTION

The present invention relates generally to a device unit and methods fortreatment of pain, and, more particularly, to delivering pulsedelectrical or electromagnetic energy in a non-invasive, patient-specificmanner.

BACKGROUND OF THE INVENTION

Over the past 12 years, probably over 10,000 patient treatments havebeen given with treatment units for relieving pain. These treatmentsinclude a diverse range of patients—young, old, and in-between, as wellas both male and female. The patients had various states of health, fromthe extremely physical fit (e.g., professional athletes) to the out ofshape and infirmed. The patients typically have a very wide range ofpreexisting conditions, including sports and other acute injuries,long-standing chronic issues that in some cases have lasted 15+ years,and symptoms that are common byproducts of just completed surgery.

The initial goal of these treatments and associated technology has beento reduce or eliminate people's pain, which has been accomplished to adegree. However, one problem associated with these previous treatmentsis that they have a cumulative effect and take many treatments,sometimes of long durations, to achieve some form of enduring painrelief. Often it would take as many as 15-20 treatments over many weeks,and individual treatments could take thirty minutes or more. Becausedurable outcomes require many treatments and a significant timecommitment from the patient, the number of treatments and the timeperiod involved (3-5 weeks) is an impediment to the patient's commitmentto continue to come for treatments, which in turn is a great inhibitorto great, enduring outcomes.

Yet another problem with current treatment units is that they do notdisplay elapsed treatment time for session time in a specific treatmentlocation that is resettable for each treatment location or in a formthat is understandable by laypeople. Without a meaningful timer thatshows these times in a layperson-understandable form, there is a highpotential for under treatment, which greatly diminishes patientoutcomes.

Yet another problem with current treatments is that the wide rangingoptions for adjusting the frequency of the treatment current and thealmost unlimited ways the treatment provider can place the treatmentprobes on the patient's body create endless permutations andcombinations of treatments, many or most of which being sub-optimal andleading to less-efficacious outcomes. Further, these sub-optimaltreatment choices made by the treatment provider can often create onlytransient pain relief, rather than healing for the underlying conditionand/or long-term pain relief. With approximately 24% of patients havingno meaningful pain relief, the opportunity for more carefully consideredor precise therapy, both in terms of electrical composition and probeplacement, is to reduce the numbers of patients for whom the therapy hasnot worked.

Thus, there is a great need for providing a treatment unit andassociated method that is more precise in optimizing the opportunityoffered by the technology to not only provide enduring pain relief butto also heal and/or to prevent or reduce the above and other problems.

SUMMARY OF THE INVENTION

The term embodiment and like terms are intended to refer broadly to allof the subject matter of this disclosure and the claims below.Statements containing these terms should be understood not to limit thesubject matter described herein or to limit the meaning or scope of theclaims below. Embodiments of the present disclosure covered herein aredefined by the claims below, not this summary. This summary is ahigh-level overview of various aspects of the disclosure and introducessome of the concepts that are further described in the DetailedDescription section below. This summary is not intended to identify keyor essential features of the claimed subject matter. This summary isalso not intended to be used in isolation to determine the scope of theclaimed subject matter. The subject matter should be understood byreference to appropriate portions of the entire specification of thisdisclosure, any or all drawings and each claim.

According to an embodiment of the present disclosure, a method isdisclosed of treating pain or inflammation or a wound in a patient toreduce or treat the pain or inflammation or wound. The method includesthe steps of: initiating a first treatment cycle using a patienttreatment unit, the first treatment cycle including: placing a firstconductor and a second conductor at first and second locations ontoliving tissue of a body of a human or animal in an area where pain orinflammation or wound is indicated, the first conductor having anelectrically conductive tip, the first and second conductors beingelectrically coupled to the patient treatment unit having a first timerdisplay configured to display a resettable timer, applying firm pressureto at least the first conductor while the tip contacts the livingtissue, causing electrical energy to be delivered through the first andsecond conductors and into the tissue in the form of a treatment signalsupplied by the patient treatment unit, the treatment signal including apulse train of direct current (DC) pulses having a pulse frequency in arange between 18 and 22 kiloHertz (kHz), a pulse current from 0.1milliAmperes (mA) to 6.0 mA, and a pulse voltage dependent on a variablesupply voltage supplied to the probe stimulus generator circuit andproviding a maximum pulse voltage of about 165 Volts of DC (VDC).

The method further includes, during the first treatment cycle,monitoring an elapsed time of the first treatment cycle on the timerthat starts from the initiating the first treatment cycle and ends uponcessation of delivery of the electrical energy to end the firsttreatment cycle; terminating the first treatment cycle and stopping thetimer; initiating a second treatment cycle, which includes: keeping orplacing the first conductor at the first location or a new location ontothe body while applying firm pressure to at least one of the firstconductor or the second conductor, causing the electrical energy to bedelivered through the body, and holding the first conductor stationaryduring at least part of the second treatment cycle or moving the firstconductor along the body during at least part of the second treatmentcycle while maintaining firm pressure on the first conductor, andmonitoring an elapsed time of the second treatment cycle on the timerthat restarts upon the initiating the second treatment cycle. The methodincludes terminating the second treatment cycle.

The first treatment cycle lasts 2-5 minutes, and the second treatmentcycle has the same or a different duration relative to the firsttreatment cycle. The second treatment cycle lasts a shorter durationrelative to the first treatment cycle. The first treatment cycle furtherincludes monitoring an impedance or conductivity of the body andresponsive to observing no change therein during the first treatmentcycle, maintaining the first conductor at the same location in thesecond treatment cycle. The first treatment cycle includes moving thefirst conductor during at least part of the first treatment cycle. Thefirst treatment cycle includes moving the second conductor during atleast part of the first treatment cycle towards or away from the firstconductor.

The same firm pressure is applied to the first conductor and to thesecond conductor during at least one of the first treatment cycle or thesecond treatment cycle. The firm pressure includes an applied weight of0.05 to 10 pounds. The timer is displayed in decimal minutes and secondsformat.

The terminating the first treatment cycle is carried out by picking upat least one of the first conductor or the second conductor from thebody to interrupt the delivery of the electrical energy through the bodyor by selecting a switch on the first conductor or on the secondconductor or on the patient treatment unit to stop the delivery of theelectrical energy regardless of whether the first and second conductorsare touching the body.

The placing the first conductor includes placing the first conductor atan approximately orthogonal orientation relative to a surface of thebody. The surface of the body corresponds to a finger, a knee, ashoulder, a hip, a joint, or a nerve on the body. The placing the firstconductor includes placing the first conductor at approximately a 45degree angle relative to a muscle on the body.

The first treatment cycle includes moving the first conductor during atleast part of the first treatment cycle, the moving the first conductorincluding moving the first conductor around the muscle to treat a muscletrigger point on the body while maintaining the first conductor atapproximate the 45 degree angle relative to the body. The firsttreatment cycle includes moving the first conductor during at least partof the first treatment cycle, wherein the electrically conductive tip isrounded and has a diameter of ¼ inches. The second conductor includes anelectrically conductive tip that is rounded and has a diameter of ¼inches.

The method can further include repeating the first treatment cycle orthe second treatment cycle one or more times to accumulate a totalelapsed treatment time, the total elapsed treatment time not exceeding10 minutes and the first treatment cycle or the second treatment cycledoes not exceed 4 minutes.

A total elapsed treatment time does not exceed 8 minutes. The methodsherein can be used to treat pain, or inflammation, or a wound in thehuman or animal. The wound can include a diabetic wound, an ulcer, aninfection, a cut, or an incision wound.

According to another embodiment of the present disclosure, a method oftreating pain or inflammation or a wound in a patient to reduce oreliminate the pain or inflammation or wound is disclosed. The methodincludes: initiating a treatment cycle by placing a first conductor anda second conductor onto living tissue of a body of a human or animal inan area where pain or inflammation or wound is indicated, the firstconductor having a rounded tip that is electrically conductive, thefirst and second conductors being electrically coupled to a patienttreatment unit having a first timer display configured to display aresettable running timer; applying firm pressure to at least the firstconductor while the rounded tip is pressed against the living tissue;causing electrical energy to be delivered through the first and secondconductors and into the tissue in the form of a treatment signalsupplied by the patient treatment unit, the treatment signal including apulse train of direct current (DC) pulses having a pulse frequency in arange between 18 and 22 kiloHertz (kHz), a pulse current from 0.1milliAmperes (mA) to 6 mA, and a pulse voltage dependent on a variablesupply voltage supplied to the probe stimulus generator circuit, thevariable supply voltage providing a maximum pulse voltage of about 165Volts of DC (VDC).

The method includes, while maintaining the firm pressure on the firstconductor as the electrical energy is supplied through the body, movingat least the first conductor along the body in a direction along which apain signal traverses the body and monitoring an elapsed time oftreatment on the running timer starting from a start of the delivery ofthe electrical energy through the conductors; responsive to the elapsedtime lasting a first duration, stopping the timer and picking up the atleast first conductor and placing at least the first conductor at thesame or a new location on the body and applying the firm pressure there;and resetting the timer.

The placing the first conductor includes placing the first conductor atan approximately orthogonal orientation relative to a surface of thebody. The surface of the body corresponds to a finger, a knee, ashoulder, a hip, a joint, or a nerve on the body. The second conductorhas a rounded tip that is electrically conductive and is held stationaryon the body while the first conductor is moved. The second conductor hasa rounded tip that is electrically conductive, the method furthercomprising moving the second conductor along the same direction as thefirst conductor or in a different direction as the first conductor ismoved while maintaining the firm pressure on the second conductor. Thefirm pressure is in a range between 0.5 lbs/in2 and 150 lbs/in2.

The method can further include repeating the treatment cycle anadditional one or more times such that a total elapsed treatment timedoes not exceed 10 minutes. A total elapsed treatment time does notexceed 8 minutes. A total elapsed treatment time does not exceed 6minutes, and a duration of the treatment cycle does not exceed 4minutes.

The method can further include repeating the treatment cycle anadditional one or more times until the patient subjectively reports areduction in the pain or until the objective impedance measurement takenon the treated areas of the patient drops below a threshold. Thereduction in pain is at least 50% following the repeating. The reductionin pain is at least 70% following the repeating. The threshold of theobjective impedance measurement is 20% of the impedance measurement at astart of the first duration. Responsive to the placing at least thefirst conductor at the same or the new location, the method can furtherinclude moving the first conductor along the body while applying firmpressure thereto.

The placing the first conductor includes placing the first conductor atapproximately a 45 degree angle relative to a muscle on the body.Responsive to the placing at least the first conductor at the same orthe new location, the method can include moving the first conductoralong the body while applying firm pressure thereto, the moving thefirst conductor includes moving the first conductor around the muscle totreat a muscle trigger point on the body while maintaining the firstconductor at approximate the 45 degree angle relative to the body.

The method can be carried out while the human or animal is awake andalert and not under any medication to affect a conscious state of thehuman or animal, and the human or animal is in a prone or seatedposition at all times throughout.

According to yet other embodiment of the present disclosure, a patienttreatment unit or device is directed to delivering non-invasive pulsedenergy to living tissue. The patient treatment unit includes a probestimulus generator circuit configured to output, as a treatment signal,a sequence of direct current (DC) electrical pulses. The DC electricalpulses are outputted at a controlled pulse frequency of about 20kiloHertz (kHz) and having a pulse voltage defined by a variable supplyvoltage of the probe stimulus generator circuit. The patient treatmentunit further includes a primary probe having a rounded tip configured tocontact a body of a human or animal. The primary probe is electricallycoupled to the probe stimulus generator circuit so as to receive the DCelectrical pulses. The patient treatment unit further includes asecondary probe configured to contact the body. The secondary probe iselectrically coupled to the probe stimulus generator circuit to completean electrical circuit with the primary probe through the body. Thepatient treatment unit further includes an intensity adjustment circuitconfigured to control the variable supply voltage, which includessetting the variable supply voltage to a predefined starting voltageupon activation of the probe stimulus generator circuit. The patienttreatment unit includes an electronic timer display configured todisplay an elapsed time in human-understandable decimal numbers inminute and second format. The elapsed time is starting from eachactivation of the probe stimulus generator circuit and running until acorresponding deactivation of the probe stimulus generator circuit. Anelectrical current of the DC electrical pulses is in a range between 0.1milliAmperes (mA) and 6 mA or 8.9 mA while the primary and secondaryprobes are contacting the body. An operating output voltage across theprimary and secondary probes while conducting the treatment signal doesnot exceed a maximum operating output voltage in a range of 150 to 165Volts of DC (VDC) while the primary and secondary probes are contactingthe body. As used herein, the terms probe, conductor, and electrode maybe used interchangeably.

According to another embodiment of the present disclosure, a method oftreating pain in a patient is intended to reduce or eliminate the pain.The method includes applying with firm pressure a first probe and asecond probe to living tissue of a patient in an area where pain isindicated. The method further includes causing electrical energy to bedelivered through the probes and into the tissue in the form of atreatment signal. The treatment signal includes a pulse train of directcurrent (DC) pulses having a pulse frequency of about 20 kiloHertz(kHz), a pulse current from 0.1 milliAmperes (mA) to 2.5 mA or 6 mA or8.9 mA for a defined range of load impedance (taken from a range ofhuman children and adults, for example), and a pulse voltage dependenton a variable supply voltage supplied to the probe stimulus generatorcircuit. The variable supply voltage provides a maximum pulse voltage ofabout 165 Volts of DC (VDC. While maintaining the firm pressure on theprobes, the method further includes moving the probes along the livingtissue of the patient in a direction along which a pain signal traversesa body of the patient. The method further includes picking up the probesand moving the probes to the same or a new location on the patient. Themethod further includes repeating the moving and picking up steps one ormore times until the patient subjectively reports a reduction in thepain or until an objective impedance measurement taken on the treatedareas of the patient drops below a threshold. The method furtherincludes tracking an elapsed time of treatment by starting at eachactivation of the treatment mode and stopping at each correspondingdeactivation of the treatment. The method further includes displayingthe elapsed time of treatment in a minutes and seconds format.

According to yet another embodiment of the present disclosure, a patienttreatment unit includes a probe stimulus generator circuit that, whilein active operation, generates a treatment signal. The treatment signalincludes a pulse train of direct current (DC) pulses having a pulsefrequency of about 20 kiloHertz (kHz), a pulse current from 0.1milliAmperes (mA) to 2.5 mA or 6 mA or 8.9 mA for a defined range ofload impedance, and a pulse voltage dependent on a variable supplyvoltage supplied to the probe stimulus generator circuit. The variablesupply voltage provides a maximum pulse voltage of about 165 Volts of DC(VDC). The patient treatment unit further includes a pair ofelectrically conducting probes coupled to the probe stimulus generatorcircuit. The pair of electrically conducting probes are for conductingthe treatment signal through a body of a human or animal patient, as theload impedance, via non-invasive contact with skin of the patient. Thepatient treatment unit further includes a mode control circuitconfigured to activate and deactivate a treatment mode of the patienttreatment unit in response to operator input. The treatment mode ischaracterized by the active operation of the probe stimulus generatorcircuit. The patient treatment unit further includes an intensityadjustment circuit configured to control the variable supply voltage tostart at a predefined starting voltage for each activation of thetreatment mode. The patient treatment unit further includes a visualdisplay unit configured to display an elapsed time of treatment bystarting at each activation of the treatment mode and stopping at eachcorresponding deactivation of the treatment, the elapsed time oftreatment being displayed in a minutes and seconds format.

The above summary is not intended to represent each embodiment or everyaspect of the present disclosure. Rather, the foregoing summary merelyprovides an example of some of the novel aspects and features set forthherein. The above features and advantages, and other features andadvantages of the present disclosure, will be readily apparent from thefollowing detailed description of representative embodiments and modesfor carrying out the concepts and aspects of the present disclosure,when taken in connection with the accompanying drawings and the appendedclaims. Additional aspects of the disclosure will be apparent to thoseof ordinary skill in the art in view of the detailed description ofvarious embodiments, which is made with reference to the drawings, abrief description of which is provided below.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure, and its advantages and drawings, will be betterunderstood from the following description of exemplary embodimentstogether with reference to the accompanying drawings. These drawingsdepict only exemplary embodiments, and are therefore not to beconsidered as limitations on the scope of the various embodiments orclaims.

FIG. 1 is a functional block diagram illustrating circuit components ofa patient treatment unit, according to an aspect of the presentdisclosure.

FIG. 2A is a front view illustration of the patient treatment unit ofFIG. 1.

FIG. 2B illustrates a primary probe of the patient treatment unit ofFIG. 1, according to one embodiment.

FIG. 2C illustrates a secondary probe of the patient treatment unit ofFIG. 1, according to one embodiment.

FIG. 3A illustrates a switch of a primary probe, according to anotherembodiment, in a back position of various treatment positions andintensity levels.

FIG. 3B illustrates a switch of the primary probe of FIG. 3A in the backposition with an intensity dial turned towards the back position.

FIG. 3C illustrates a switch of the primary treatment probe of FIG. 3Ain the forward position with the intensity dial turned towards theforward position.

FIG. 3D illustrates a switch of the primary treatment probe of FIG. 3Ain the back position with the intensity dial turned towards the forwardposition.

FIG. 4 is a circuit diagram of a waveform generator of the patienttreatment unit of FIG. 1.

FIG. 5A is a process flow diagram outlining a method of analyzing andtreating pain using a patient treatment unit.

FIG. 5B is a continuation of the process flow diagram of FIG. 5A.

FIG. 5C is a continuation of the process flow diagram of FIG. 5B.

While the invention is susceptible to various modifications andalternative forms, specific embodiments have been shown by way ofexample in the drawings and will be described in detail herein. Itshould be understood, however, that the invention is not intended to belimited to the particular forms disclosed. Rather, the invention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION

Various embodiments are described with reference to the attachedfigures, where like reference numerals are used throughout the figuresto designate similar or equivalent elements. The figures are not drawnto scale and are provided merely to illustrate the instant disclosure.Several aspects of the disclosure are described below with reference toexample applications for illustration. It should be understood thatnumerous specific details, relationships, and methods are set forth toprovide a full understanding of the disclosure. One having ordinaryskill in the relevant art, however, will readily recognize that thedisclosure can be practiced without one or more of the specific details,or with other methods. In other instances, well-known structures oroperations are not shown in detail to avoid obscuring the disclosure.The various embodiments are not limited by the illustrated ordering ofacts or events, as some acts may occur in different orders and/orconcurrently with other acts or events. Furthermore, not all illustratedacts or events are required to implement a methodology in accordancewith the present disclosure.

Elements and limitations that are disclosed, for example, in theAbstract, Summary, and Detailed Description sections, but not explicitlyset forth in the claims, should not be incorporated into the claims,singly, or collectively, by implication, inference, or otherwise. Forpurposes of the present detailed description, unless specificallydisclaimed, the singular includes the plural and vice versa. The word“including” means “including without limitation.” Moreover, words ofapproximation, such as “about,” “almost,” “substantially,”“approximately,” “generally,” and the like, can be used herein to mean“at,” “near,” or “nearly at,” or “within 3-5% of,” or “within acceptablemanufacturing tolerances,” or any logical combination thereof, forexample.

Non-invasive, drug-free treatment and amelioration of pain are endeavorsthat many have attempted to address through a myriad of therapeuticmethods and stimulation means. One area of focus has been theapplication of electrical energy directly to the skin of a person beingtreated for a pain condition through metal probe tips that deliver aspecific form of energy into the tissue. One early effort to use metalprobe tips placed in direct contact with the skin is described in U.S.Pat. No. 8,064,988, which disclosed a very wide range of a billionfrequencies ranging from 1 Hertz (Hz) to 1 Gigahertz (GHz), togetherwith flux densities of 0.1 Gauss to 4 Telsa (or 40,000 Gauss), or arange of 400,000 Gauss, and pulse widths spanning 0.34 milliseconds (ms)to 0.74 ms. Only one specific low frequency was disclosed in the rangeof 1 Hz to 490 Hz. Later, in for example, U.S. Pat. No. 10,085,670, anadditional specific frequency range between 4 Kilohertz (kHz) and 20 kHzwas disclosed, in addition to the low frequency range of 1-490 Hz. Amachine was disclosed with a frequency selector, allowing the operatorto switch between low and high frequency ranges and to vary thefrequency applied via the probes. While this later patent reduced theranges of frequencies from a billion, the skilled person still had arange of over 16,500 Hertz to experiment with, not to mention the manyother electrical parameters disclosed in these patents (amplitude, pulsewidth, duty cycle, energy content). Moreover, no quantification ofpressure was disclosed in U.S. Pat. No. 8,064,988, nor was there anyappreciation that pressure and specific electrical characteristics areparticularly efficacious at reducing pain in a very short period of time(e.g., less than 10 minutes). No indication of how much time theenergized probes should be placed on the patient, nor any appreciationthat the angle that the probes are placed on the body makes anymeaningful difference on the reduction in pain. No appreciation wasgiven as to whether movement of one or more probes is efficacious atreducing pain.

Since then, according to this disclosure, it has been discovered, withastonishing results, that at least one specific range of frequencycentered around 20 kHz (plus or minus 10%) is particularly effective atreducing, or in many instances, completely eliminating certain types ofpain including certain types of chronic pain, together with additionalelectrical parameters. Moreover, it has also been found that a firmpressure, described below, should be applied on at least one of theenergized probes, the angle of the primary probe can be importantdepending on the area being treated (e.g., joint versus muscle),movement of at least the primary probe can be used to “chase the pain,”and there can be a point of diminishing return by over-applying energyto the area being treated for an extended period of time. These andother insights in combination have produced surprising and dramaticreductions in pain and even inflammation, and can also be used in woundtreatment to speed up wound healing time as well as to reduce painaround the wound site. Wounds that can be healed using the devices andmethods disclosed herein include diabetic wounds, ulcers, infections,cuts, and incision wounds.

The treatment times have been dramatically reduced, and subjectivereports indicate that patients feel a substantial reduction in painafter only a single application of probe-delivered electrical energycentered around 20 kHz or in a range of approximately 18-22 kHz, andmany report feeling zero pain following one treatment applicationlasting just a few minutes. Moreover, it has also been discovered inaccordance with the present disclosure that certain force pressures,placements, and/or movements of the electrical probes during applicationof a treatment can also enhance the efficacy of treatment andsubstantially reduce treatment times. As a result, treatment times havefallen from many minutes to just a few minutes, and within a treatmentwindow lasting just a few minutes or no more than 8 or 10 minutes, theoperator of the probes needs to be guided by some visual cue as to whento move a probe or how long a probe has been applying energy at a staticlocation on the skin. Some patients have reported a 100% reduction inpain, or no pain at all despite starting from a 10 out of 10 prior totreatment, within less than 8 minutes of treatment modalities disclosedherein.

A treatment timer circuit is disclosed in U.S. Pat. No. 10,085,670,which displays elapsed time as a hexadecimal number, and was used withan algorithmic evaluation code display 216 to “ensure compliance forboth medical outcomes and insurance requirements.” At the start of eachpatient treatment session, the hexadecimal algorithmic evaluation code(AEC) needed to be noted and recorded in the patient's file. This AECcode never reset, and was portrayed as a hexadecimal number instead ofdecimal numbers and represented a total accumulated treatment time usedby the patent treatment unit. The use of hexadecimal numbers (e.g.,AE01) made it difficult for the operator to understand how many secondshave elapsed from one treatment to another, and unless the caregiverwere familiar with hexadecimal numbers, the AEC counter would not haveconveyed any meaningful information to that caregiver. Moreover, becausethe timer did not reset, the caregiver operator had to jot down or makea mental note of the treatment times from one therapy application toanother. This would lead to over-treatments, inconsistent treatmenttimes, confusion by the caregiver operator, and to the operator simplyignoring the AEC codes, resulting in overall sub-optimal treatmentefficacy and sometimes over-treatment of an area with diminishing orcounterproductive benefit.

It has been determined according to the present disclosure that certaintreatment protocols yield particularly effective results and that timingis a key element of such protocols. Timing becomes even more importantwith the discovery of increased efficacy and concomitant reduction inrequired treatment durations when using treatment frequencies in the 18kHz-22 kHz range. In addition, with the discovery that probe applicationof DC pulses having a frequency centered around 20 kHz is highlyeffective at treating certain pain conditions, leading to complete painrelief within just a few minutes of a single application of treatment,it has been found to be advantageous to clearly inform the caregiveroperator how much treatment time has elapsed of delivery of electricalenergy to the patient to ensure that the probes are manipulated on thepatient's skin in an optimum manner and for optimum time periods.Moreover, the timer can be used as a training tool to aid noviceoperators in using the device and manipulating the probes to deliver themost efficacious treatment strategy to a situs of pain or inflammationor a wound. Because the treatment times when using the treatmentmodalities herein are so short in duration (e.g., 1-4 minutes from thestart of the delivery of electrical energy through the body to thecessation of the delivery of electrical energy), the timer showing theelapsed time since the start of the delivery of electrical energy isimportant to inform the caregiver when the stop delivering energy and/ormove one or both probes to a new location.

In addition to the energy characteristics applied to the body, thepressure applied to the body while the energy is being delivered throughthe electrical conductor is also important in the efficacy of treatingpain and reducing the treatment times. A range of firm pressure shouldbe applied to least one of the electrical conductors as the energy isbeing applied through the conductor contacting the body of the patientbeing treated.

Conventional TENS electrodes that adhere to the patient's body, applynegligible pressure to the body. A typical TENS electrode weighsapproximately 0.0055 lbs, and other than surface tension applied by theadhesive material, there is a negligible amount of pressure applied tothe patient's skin while energy is being delivered through the TENSpatch. It has been found that pressure should be applied to theconductor while the energy is being applied therethrough. If thepressure is too light, the efficacy of the treatment fallssignificantly. If the pressure is too hard, the patient can experiencediscomfort without a concomitant improvement in efficacy. The amount ofpressure that can be applied for optimum efficacy also depends on thegeometry of the tip of the electrode or conductor contacting the body.Given the range of bodies that the aspects of the present disclosure canbe applied to, a minimum pressure expressed as a weight to be applied tothe conductor while contacting the body of a person and while deliveringthe electrical energy disclosed herein is 0.05 lbs (pounds), assuming ahemispherically-shaped or rounded tip on an elongated probe having adiameter of 0.25 inches. A maximum pressure should not exceed 10-15 lbsfor the same probe tip. For larger (tip surface area) probe tips, ahigher maximum weight or pressure can be tolerated by most patients(e.g., closer to 15 lbs or higher); for smaller (tip surface area) probetips, a lower maximum weight or pressure can be tolerated (e.g., closerto 10 lbs).

However, for different geometries of the tip of the conductor contactingthe body, a higher ceiling of pressure can be applied, such as, forexample, 16 lbs depending on the size and weight of the person. Theacceptable pressure ranges contemplated herein at the surface of the tipor end of the conductor that makes contact with the body will beexpressed herein as pounds per square inch (PSI), assuming a contactsurface area corresponding to a round area having a diameter of 0.25inches.

Using a weight range of 0.05 lbs to 15 lbs, an acceptable range ofpressure (expressed as PSI) in one embodiment can be between a minimumof 0.5 lbs/in2 to a maximum of 150 lbs/in2 (or 0.05 lbs to 15 lbs). Inother embodiments, the minimum PSI can be any value between 0.6 lbs/in2and 10 lbs/in2 (or 0.06 lbs to 1 lb). In still other embodiments, theminimum PSI can be any value between 0.6 lbs/in2 and 15 lbs/in2 (or 0.06lbs to 1.5 lbs). In yet other embodiments, the minimum PSI can be anyvalue between 0.6 lbs/in2 and 20 lbs/in2 (or 0.06 lbs to 2 lbs). In afurther other embodiment, the minimum PSI can be any value between 0.6lbs/in2 and 25 lbs/in2 (or 0.06 lbs to 2.5 lbs). In a still furtherother embodiment, the minimum PSI can be any value between 0.6 lbs/in2and 30 lbs/in2 (or 0.06 lbs to 3 lbs). In yet another other embodiment,the minimum PSI can be any value between 0.6 lbs/in2 and 35 lbs/in2 (or0.06 lbs to 3.5 lbs). In a still further embodiment, the minimum PSI canbe any value between 0.6 lbs/in2 and 40 lbs/in2 (or 0.06 lbs to 4 lbs).In another embodiment, the minimum PSI can be any value between 0.6lbs/in2 and 45 lbs/in2 (or 0.06 lbs to 4.5 lbs). The minimum pressurethreshold depends upon one or more of the following: the shape andgeometry of the end surface of the conductor contacting the body, thearea being treated, the size of the patient being treated, a thicknessof the tissue with which the conductor makes contact, the age of thepatient. In some embodiments, the maximum PSI can be 100 or 110 or 120or 130 or 140 lbs/in2. Assuming a primary probe tip diameter of ¼″, themaximum weight that should be applied to the tip when pressed againstthe body is 10 or 11 or 12 or 13 or 14 or 15 pounds. The term “firmpressure” as used herein refers to any operating conductor pressurerange within any minimum and maximum quantity disclosed herein, whetherexpressed as weight (e.g., in pounds, kilograms, or equivalent) orpressure (e.g., pounds or kilograms per square inch or per squarecentimeter or equivalent), or any other measure by which pressure(compressive force) is quantified. These pressure quantities assume aprobe that is positioned relatively orthogonal to the surface of thetissue being treated, although the present disclosure explicitlycontemplates that angles between 45-90 degrees can be used depending onthe area being treated. Even when the primary probe is held against thebody with firm pressure at an angle other than 90 degrees, it isimportant to maintain a firm pressure on the probe while the tip iscontacting the body and energy from the probe is being delivered intothe body. In some embodiments, approximately the same firm pressure isapplied to both probes 103, 105 when energy is being delivered to thebody; in other embodiments, different firm pressure values can beapplied to the probes 103, 105. The pressure on the probes determines,in part, a depth that the energy penetrates into the tissue, so thepressure on the probes can be independently adjusted to pinpoint thepain within the tissue.

The present disclosure is also efficacious at wound treatment, so whenapplying a conductor onto a wound, lighter pressure should be used toavoid discomfort to the patient, but the most pressure a patient cancomfortably tolerate without causing further damage or injury to thewound should be applied. For ease of discussion, the range of pressureapplied to the body of a patient by an electrical conductor or probe orelectrode can be referred to herein as the operating conductor pressurerange. Stated differently, a pressure within the operating conductorpressure range is considered to be a firm pressure as used herein.Pressure that falls below the operating conductor pressure range isconsidered to be light pressure, and pressure above the operatingconductor pressure range is considered to be excessive pressure. In allapplications herein, firm pressure should be applied to at least one ofthe conductors through which energy is being delivered to the body ofthe patient receiving treatment. In one particular application, a weightapplied to the conductor tip in the range of 0.1 lbs to 4 lbs, or apressure between 1 to 40 lbs/in2 (PSI) using a ¼″ hemispherical roundedprobe tip, is found to be particularly efficacious at treating a widevariety, but not all, of conditions and relatively insensitive treatmentlocations (e.g., the top of the foot is particularly sensitive and alighter pressure should be used there so as not to cause discomfort tothe patient undergoing treatment). This range of weight pressure iseffective for a wide range of treatment applications and locations, butnot all.

Generally, one aspect of the present disclosure relates to a treatmentunit or device for delivering non-invasive, optimized, andpatient-specific pulsed electromagnetic energy while applying pressurewithin an operating conductor pressure range, which not only eliminatesor reduces acute or chronic pain, but further heals the body of apatient. The treatment unit and associated method actually improve theunderlying condition that causes pain to emanate in the first place.Rather than simply disrupt the communication of a pain signal, thetreatment actually changes the underlying physiology such that a paininducing condition is remediated. It is believed that in some treatmentapplications, the combination of pressure within the operating conductorpressure range and the application of pulsed DC energy having afrequency centered around 18-22 kHz optimally reduces pain in theshortest amount of time. These realizations occurred only afterconducting many thousands of treatments and soliciting real-time patientfeedback using a variety of different electrical energies and pressuresover a period of many years. Other realizations include the startinglocation of the initial position of the electrodes or conductors on thebody and how one of those conductors are moved along the body, whichdepends on the situs of the pain and the type of pain (e.g., tenniselbow versus foot sprain); the amount of time a conductor is held in oneposition; the angle of one or both conductors relative to the tissue;the total treatment time during a treatment visit (e.g., a treatmentvisit ends when there is at least a 60 minute period during which noenergy is applied to treat the patient, and a new treatment visit startswhen at least 60 minutes have elapsed since the last application ofenergy to the patient under treatment).

Several differences including those mentioned above distinguish thetreatment unit and methods of the present disclosure from previoustreatments. These differences make the disclosed technology go beyondstrictly pain relief into healing the body. For example, one differenceis related to broadening the treatment objective from stopping the painto also healing the underlying condition. The change in treatmentobjective greatly impacts which body parts are provided with treatment.Instead of simply treating at the source of where the patient perceivespain to be emanating from, the present treatment instead focuses onwhere the underlying condition is occurring and treat that specific bodypart. In many cases, the present disclosure requires multiple locationsthat must be treated. This also has implications as to how long eachlocation must be treated, which requires an integrated timer (that isunderstandable to a human) into the treatment unit to help the treatmentprovider give the most efficacious treatment in an efficient manner.

The treatment unit of the present disclosure delivers pulsedelectromagnetic energy non-invasively to a patient's involved area. Thetreatment unit reduces both acute and chronic pain, and with appropriatefollow-up treatments can eliminate the pain long term. The currentdelivered by the treatment unit is defined by a novel set of parameters,which has been thoroughly developed, refined, and researched. Within thetreatment unit's configuration are specific characteristics of theelectromagnetic current delivery that differentiate the treatment unitfrom other electric current generating devices, including one or more ofthe following: (1) a specific frequency of about 20 kHz, (2) a specificDC current in the range of 0.1-2 mA or 0.1-6 mA or 0.1-8.9 mA, (3) amaximum operating output voltage of 165 Volts of direct current (VDC),(4) use of direct vs. alternating current, (5) at least one moveableprobe or electrode or conductor as a delivery mechanism of theelectrical energy, (6) the angle of the moveable conductor, (7) thepressure applied to the body by the moveable conductor while electricalenergy is being provided therethrough, (8) two human-readable timersshowing the elapsed time (resettable) when energy is being applied tothe body and a lifetime timer (non-resettable) showing how muchaccumulated time that energy has been delivered by the treatment unit inits lifetime.

The importance of the frequency of the pulsed current (especially directcurrent) cannot be overstated. At this higher frequency, both currentperception thresholds and let-go thresholds are significantly increased.It is possible to employ significantly higher intensities up to 165Volts (V), as a patient can easily tolerate this high level of intensityin most cases without even feeling any sensation at all. This is theopposite of lower frequency electrical modalities, which can be painfuland difficult for a patient to tolerate, limiting the intensity that canbe utilized. The lack of any discomfort with the disclosed treatmentunit's higher frequency allows the treatment provider to use thetreatment unit's full intensity of treatment, which in turn enhancesefficacy. Full intensity also enables shorter treatment times to beefficacious. And, at the higher frequency, the treatment unit utilizesvery quick, short pulses, which keep the volumetric delivery of energyper pulse low, thus enhancing patient safety.

The frequency current of the treatment unit plays a key part in theability to deliver the current non-invasively, and, yet, penetrate theepidermis to reach deep into a patient's tissue. Skin itself has a veryhigh level of resistance that can make electromagnetic therapy difficultto deliver beyond the skin and deep into the patient. The high impedanceof the skin can be attributed to the lipids of the stratum corneum.However, frequency current with sufficient voltage and short pulselengths can create “pores” within the skin lipid bilayer, creating atransdermal channel into the depths of tissue. For example, thetreatment unit's 20 kHz carrier frequency, with a 50 V output, satisfiesthese criteria. Furthermore, in some instances, the treatment unit'shigh frequency and short pulse widths allow the body's tissues to act assort of condensers. This increased capacitance consequently results inthe relieving effects of the treatment unit to persist long after thetreatment ends.

The 20 kHz frequency capability of the treatment unit is extremelybeneficial. In fact, at a current at about 20 kHz (e.g., plus or minus 2kHz) a complete nerve block is achievable, which is not seen at otherfrequencies. The 20 kHz±2 kHz frequency, like the one used with thetreatment unit, impacts the voltage-controlled gates and the instigationof second messengers, and triggers a myriad of other beneficialbiological actions. At the same time, this 20 kHz frequency makes thecurrent virtually undetectable to the patient, and, with short pulses,safely delivers higher voltage levels that can be used by the treatmentprovides to generate better outcomes than other electromagnetictherapies.

The treatment unit further utilizes a pulsed direct current thatdelivers a polarity effect unlike the majority of electrical therapeuticdevices, which commonly use an alternating current. Direct current hasbeen proven to be especially beneficial for skeletal and neurologicalconditions, as well as for wound healing. In fact, direct currentpromotes peripheral nerve regeneration and, in post-surgical patients,it also expedites nerve function recovery that can contribute to abetter healing process. While prior art disclosed DC current, it did notappreciate the combination of energy characteristics that are disclosedherein, which offer the most efficacious pain treatment in anastonishingly short amount of time.

When tissues are damaged, as is the case with surgical incisions, anelectrical potential is created between the healthy and damages tissues.This, and other evidence, suggests that wound healing may be partlycontrolled by electrical signals and, hence, that electrical therapymight influence wound healing. Many clinical investigations over thepast 25 years have found that electrical stimulation leads to enhancedwould healing. Results for many of the investigations indicate that thehealing rate is approximately double in the electrically treatedpatients. A direct current is the common thread through the research ofthese investigations. The polarity effect between the anode and cathodeappears to have particular consequences to the tissue. The low-intensitydirect current may reduce the time needed for superficial wound healing1.5-2.5 times compared to wounds not receiving such treatment. This formof electrical current can encourage hydration, increase the number ofgrowth factor receptors, increase the rate of collagen formation,stimulate the growth of fibroblasts and granulation tissues, and/orreduce the number of mast cells in the injured area.

Alternating current seems to be more common in other electrotherapyproducts than direct current, which makes the use of direct current inthe treatment unit contributory to its uniqueness. And, as previousstudies demonstrate, the use of direct current has many positives on theoverall therapy, which makes pulsed direct current an importantcontributor to the effectiveness of the treatment unit and how it works.

Actively-administered probes or electrodes that can be manuallymanipulated on and along the body make a meaningful difference in thetreatment unit, which offers a distinct delivery methodology via the useof the probes with stainless-steel hemispherical-shaped tips. Thecaregiver ultimately administers treatment using the probes as thedelivery mechanism, which allows for a more-concentrated, high-densitycurrent to be delivered directly to the affected area, while at the sametime applying pressure within the operating conductor pressure range.Studies have shown the importance of current density, finding that theskin's naturally high resistance can undermine electromagnetic therapyunless the density is sufficient and the frequency of the current ishigh enough to easily pass through the skin.

In contradistinction to the disclosed probes, and despite the importanceof current density and the correlation to probes as the deliverymechanism, the large majority of electrotherapeutic treatments utilizelarge electrode pads, which are adhered to the patient in a stationarymanner. The pads themselves can create a less dense, more-diffuse signaldue to their large surface area and paper-thin depth, which can makeeffective penetration of the skin more difficult, diminish the intensityof the current delivered to the involved area and ultimately makingmeaningful therapy often unobtainable. Furthermore, the mobility ornon-stationary nature of the disclosed probes vs. stationary pads allowsthe caregiver to cover more territory while still using a dense currentand to “follow the pain” as described herein. The movement also allowsthe treatment provider to flush underlying edema or inflammation, whichis highly correlated to pain, out of the area. Movement also candiminish the risk of static electrodes in the wrong or sub-optimallocation, and, thereby, undermining the treatment.

In an alternative embodiment, small-diameter (high-density) pads areused instead of or in addition to the disclosed probes. For example, inone embodiment the small-diameter pads are approximately the size of thedisclosed probe tips. For example, a small-diameter pad can be used withone probe, where the pad can be affixed or adhered to the patient whilethe probe is moved to treat the pain. The conductor that provides thereturn energy can be stationary, depending on the treatment application;or both conductors can be moveable, preferably independently of oneanother.

The disclosed electromagnetic therapy using the treatment unit isemerging as an excellent treatment option for many painful medicalconditions in which unwanted or uncoordinated generation of nerveimpulses is a major disabling factor. Existing treatment alternatives,including pharmacological and chemical treatments, or surgery, all haveserious shortcomings including that they are not consistentlysuccessful. The disclosed electromagnetic therapy may be an effectivealternative because it can elicit comparable ionic concentrations andcellular changes as traditional pharmacological nerve blocks. Thedisclosed electromagnetic therapy also offers a high degree of safetyand predictability.

As an overview, the treatment unit is an electroceutical treatment thatreduces and/or eliminates pain. Its closest frame of reference is anelectrical version of a nerve block. The treatment unit is non-invasive,and offers instant patient feedback. Furthermore, the treatment unit canbe used as frequently as needed with no known side effects. Thetreatment unit re-boots the nerves in the involved area to bring back anormal impulse so that it may supply appropriate neural control to theengaged cells. When impulses can be reset, the painful condition can bereduced or eliminated entirely. By targeting nerves that arguablycontrol all body processes, there is a cascade effect of not onlyencouraging the release of the body's natural opiates but of improvingvascular responses, which is likely responsible for the objective andinstant improvements in swelling commonly witnesses with treatments viathe treatment unit. The treatment unit uses pulsed electromagneticenergy that is delivered to the patient via a direct current through thetreatment unit's probe delivery system and at a carrier frequency thatis far higher than almost all other common electrical therapies.

Clinical research demonstrates that treatment at high frequency resultsin improved results, including fewer required treatments. A draftdocument of the study is titled “A Clinical Study of the MediPhysicsPain Treatment System for the Treatment for Chronic and Acute Pain,” byFrank L. Greenway (December 2005). For example, using a low frequency,it took 12 treatments over four weeks (3 treatments per week) toproperly treat a patient's pain. Using the low frequency, 41% of thepatients achieved a pain reduction of over 70% of their pain over the 12treatments, 33% of the patients achieved a pain reduction of 20-70%, and26% of the patients achieved little or no pain relief (less than 20%relief). Using the low frequency, each individual treatment created anaverage 52% improvement pre vs. post treatment.

In contrast, recent data from a high-frequency study shows that using ahigh frequency, such as the approximately 20 kHz frequency of thepresent disclosure, results in most patients requiring three or fewertreatments and on average only 3.6 treatments. Each treatment averaged72% pain reduction (vs. 52% improvement for low frequency). All patientsexperienced 78% or better pain reduction over the full course of theirtreatments (vs. 41% achieving over 70% at low frequency) and 84% ofpatients achieved total (100%) reduction of their pain. In anotherstudy, in which chronic orchialgia was treated, the average number oftreatments required was only 3.2 treatments per patient, and thosepatients averaged 58% reduction of pain in just 3.2 treatments.

Comparing the above results between the low frequency of the clinicalresearch and the high frequency of the high-frequency study, it is clearthat a high frequency reduces the number of treatments per patient andgreatly improves the efficacy. Although the amount of energy to which apatient is exposed per pulse is actually lower (making the treatmentsafer and better tolerated), the total amount of energy delivered to thesite of pain is actually higher because of the high frequency.

In accordance with the above unique features, the treatment unit sendselectrical pulses to the patient's tissues via primary and secondaryprobes to provide nerve stimulation to relieve the patient's pain. Thetreatment unit receives impedance measurements from a patient's tissuesusing the primary and secondary probes. As the electrical pulses areapplied, the impedance measurements are monitored, with a drop inimpedance being indicative of less resistance. Lower impedancemeasurements are correlated to lower perceived levels of pain that thepatient experiences. The treatment unit receives impedance informationfrom the patient's tissues, including the body's cellular network, and,by monitoring the received impedance information as additionalelectrical pulses are applied as pain treatment, the system and methodof the present treatment unit assesses and treats pain experienced bythe patient's tissues and other physical structures. To be clear,inventive aspects of the present disclosure are not focused on a highfrequency range as the sole point of novelty; it is the combination ofinsights disclosed herein gained over thousands of treatments spanningmany years and feedback from dozens of patients.

In assessing and treating the pain, the treatment unit applieselectrical pulse trains at the site of pain, at the tissue abnormality,or upon selected nervous system trigger points or motor points. Thesetrigger or motor points may also coincide with acupuncture or pressurepoints of the body. As the electrical pulse train is transmitted intothe tissue, it encounters the inherent impedance signature produced bythe tissue or subject matter under study. Impedance information isgenerated by this initial analysis and measurement and may be used as abaseline measurement to plan and evaluate treatment. Because theimpedance measurement is objective, it can serve as an objectiveindication of a reduction in the pain and can be used to augment orverify the patient's subjective pain assessment. From the start of apain treatment to the end of a pain treatment session, which can includemultiple cycles of energy applied through the conductors, the reductionin impedance can be at least 10% or 20% or 30% or 40% or greatercompared to the start of the pain treatment session. In other words,when the impedance drops to 80% or 70% or 60% or lower of its originalvalue when the energy is first applied through the probes, then thetreatment can be concluded as being a success and as having reduced thelevel of pain. These measurements can be used as a check against thepatient's subjective reporting of the level of pain. In some aspects,the objective impedance measurement can be used as an indication ofinsurance fraud, such as when a patient reports a subjective level ofpain that is much greater than the objective criteria. Note that anincrease in conductivity is the other side of the impedance coin. Thatis, instead of a reduction in impedance as an indication of efficacy, anincrease in conductivity indicates the same improvement. The termsreduction or decrease in resistivity or impedance means the same thingas an increase in conductivity. The conductance level display 212 shownin FIG. 2A is monitored by the caregiver. When the meter shown on thedisplay 212 represents electrical conductivity, the meter will increaseor grow as the conductivity improves. When the meter shown on thedisplay 212 represents body impedance, the meter will decrease or shrinkas the impedance drops. In either instance, the caregiver can monitorthe changes in the meter to determine when to stop applying energyduring a particular treatment cycle. As explained herein, if no movementin the meter is observed after, e.g., 3 minutes of application of energyto the body, the caregiver can decide to continue to apply energy duringthat treatment cycle for a longer duration of time, e.g., another 1minute, while monitoring for changes in the meter displayed on thedisplay 212. Like the elapsed treatment time display, the conductancelevel display 212 also serves an important visual aid to the caregiverto understand how much time duration to apply energy through the probes,and the efficaciousness of a particular energy delivery strategy duringa particular treatment cycle. A rapid change in the meter displayed onthe display 212 can also cause the caregiver to stop applying energythrough the body sooner than the caregiver would have expected, allowingthe caregiver to focus on other areas on the body, reducing the overalltreatment time.

In addition to evaluating and characterizing a patient's degree of pain,the treatment unit provides therapeutic action to alleviate the pain.The treatment unit may further provide neural stimulation to alleviatepain, reduce healing time, and upon suitable repetition of therapy,result in long-term improved pain management of the afflicted area. Painis reduced or eliminated by means of the electrical pulse train effecton nociceptive afferent neurons, which are sensitive to electricalstimuli as well as noxious stimuli including thermal, mechanical, andchemical stimuli as described above.

Referring to FIG. 1, a functional block diagram illustrates an exemplaryembodiment of a treatment unit in the form of a patient treatment unit100 that includes a probe stimulus generator circuit 101 for outputting,as a treatment signal, a sequence of DC electrical pulses at acontrolled pulse frequency of about 20 kHz (plus or minus 10%). Theprobe stimulus generator circuit 101 outputs the DC electrical pulses ata pulse voltage defined by a variable supply voltage.

The probe stimulus generator circuit 101 further controls a pulsefrequency, a pulse width, and a polarity of the electrical pulse train.Additionally, the probe stimulus generator circuit 101 outputs anelectrical pulse train that is a clean waveform, largely free ofelectrical noise by using rigid electrical component tolerances in acarrier waveform generation circuit. For example, the carrier waveformfrequency may be set using a carrier adjustment circuit in combinationwith a capacitor. This RC circuit may be adjusted to produce the desiredcarrier frequency of the electrical pulse train. The RC circuit valuesprovide a stable waveform, largely free of electrical noise.

The probe stimulus generator circuit 101 may use a number of differentelectrical pulse train configurations, depending upon the treatment athand, but in accordance with the unique parameters disclosed above. Forexample, a number of different waveforms of variable amplitude may beselected, such as a basic square wave with a pulse width of 9 to 20 usor 14 us and a pulse rate of 20,000 pulses per second, with a pulseamplitude of 100 V, may be selected to treat lower back pain.Optionally, filtering of the electrical pulse train eliminates errorsignals that often manifest as waveform ripples.

The patient treatment unit 100 further includes a primary probe 103 anda secondary probe 105 that are coupled to the probe stimulus generatorcircuit 101. As illustrated below in FIG. 2B, the primary probe 103 hasa rounded tip that is configured to contact a body of a human or animaland an elongated (dielectric) body having a diameter sufficient to begripped or grasped or held by a human hand. The elongated form factoraids in the manipulating the primary probe 103 on the skin of the humanor animal while maintaining a firm pressure thereon during applicationof the electrical energy through the probes 103, 105. The primary probe103 is electrically coupled to the probe stimulus generator circuit 101so as to receive the DC electrical pulses. The secondary probe 105 isalso configured to contact the body of the human or animal, and iselectrically coupled to the probe stimulus generator circuit 101 tocomplete an electrical circuit with the primary probe 103 through thebody of the human or animal. The secondary probe 105 can be a stationaryconductor such as one that is adhered to the body such that only theprimary probe 103 is moveable. This configuration would allow a patient,for example, to self-administer treatment via the primary probe 103while keeping the stationary probe 105 at a fixed location on the body.The primary probe 103 and/or the secondary probe 105 can optionallyinclude therein a pressure sensor, such as a pressure transducer 262(see FIG. 2B), configured to sense a pressure applied to the end of theprobe 103/105. Optionally, the probe stimulus generator circuit 101 canbe configured to require a threshold pressure to be detected via thepressure transducer before outputting the DC electrical pulses throughthe primary probe 103. Likewise, the probe stimulus generator circuit101 can be configured to cease outputting the DC electrical pulsesthrough the primary probe 103 when the detected pressure by the pressuretransducer falls below the threshold. The threshold can be set to anyvalue at the lower range of the operating conductor pressure range,e.g., 0.5 lbs/in2, and the threshold can be adjusted based on the areabeing treated and the nature of the pain being treated. For example, alower pressure threshold value can be set when the area being treated isclose to or on a bone or a sensitive area, whereas a higher pressurethreshold value can be set when the area being treated is a thicktissue, such as a thigh, or an area that is not as sensitive.

An electrical current of the DC electrical pulses is in a range of 0.1-2mA or 0.1-6 mA or 0.1-8.9 mA while the probes 103, 105 are in contactwith the body. An operating output voltage across the probes 103, 105,while conducting the treatment signal, does not exceed a maximumoperating output voltage of 165 VDC while the probes 103, 105 arecontacting the body.

The treatment unit 100 includes one or more of a body impedance analysiscircuit 107, a monitor circuit 109, an audio speaker 111, a mode controlcircuit 115, an optional sense circuit 117, a power supply circuit 121,an optional programming and debugging circuit 123, an externalinput/output connection interface 125, an optional treatment areaselection circuit 127, an intensity adjustment circuit 129, a displaydriver 135, a primary timer 136, and a secondary timer 138. The unit ispowered by an external wall wart power supply 119 to supply DC power tothe power supply circuit 121. In this example as shown by outline OL inFIG. 1, a number of the circuits 121, 107, 101, 121, 129, 109 arephysically mounted and manufactured on a single printed circuit board toreduce electrical noise between components and circuits. The printedcircuit board may be a multi-layer printed circuit board to furtherreduce ambient electrical noise and to generate a clean and error-freepulse train. As will be explained below, additional useful data may beprovided to the clinician via an interface module 150. The pair ofprobes 103 and 105 receives the electrical pulse train and apply thepulse train to the patient's body.

The probe stimulus generator circuit 101 also includes internal monitorfunctions to ensure the safety and performance of patient treatment unit100. For example, the probe stimulus generator circuit 101 monitors andchecks power supply voltage from power supply circuit 121 and optionallythe coil sense indication from sense circuit 117 that the probes 103,105 are properly connected across a proper tissue or patient.Furthermore, the mode control circuit 115 provides a handshake signalindicating a ready condition that must be detected by probe stimulusgenerator circuit 101 before a pulse train may be applied to a tissue.The probe stimulus generator circuit 101 can optionally include levelshifting circuitry that may be used to alter the carrier current as wellas to shift the current and voltage limiting circuitry. The probestimulus generator circuit 101 will not output the sequence ofelectrical pulses until the power supply handshake, optionally the sensehandshake (if present), and the treatment counter handshake signals allindicate that these circuits 121, 117, 115 are in a ready condition.

Referring to FIG. 2A, an exterior casing of the patient treatment unit100 has a front surface with a number of controls including a carrierknob 200, a sensitivity or calibration knob 202, a baseline calibrationknob 204, a power indicator light 206, a treatment time display 208, afrequency button 210, and a conductance level display 212. The carrierknob 200 controls a frequency of a carrier wave, and thesensitivity/calibration knob 202 adjusts the magnitude of a change inconductance level. The baseline calibration knob 204 adjusts the rangeof the measurement of conductivity of the patient treatment unit 100,and the power indicator light 206 indicates that the patient treatmentunit 100 is on when the light 206 glows. The treatment time display 208provides a means to track the duration of each patient's treatment, andthe frequency button 210 sets an output frequency range, e.g., switchesbetween a high and a low frequency. The conductance level display 212indicates the conductivity between the probes and is used to trackprogress being made during treatment, with scale runs, for example, from1-20. The display 212 also indicates the resistivity or impedance by itsconverse relationship with conductivity. The display 212 can instead beconfigured to indicate impedance, in which case a reduction in the meterdisplayed on the 212 represents a reduction in the impedance (and acorresponding reduction in pain or efficaciousness of treatment).

More importantly, the treatment time display 208 includes at least oneof two timer displays that show (a) a total elapsed time or total numberof treatments conducted using the patient treatment unit 100 via anaggregate treatment timer display and/or (b) a resettable session timevia an elapsed treatment timer display. The aggregate treatment timerdoes not reset, as it keeps track of the machine's total time across alltreatment sessions and/or the total number of treatment sessionsconducted using the machine. This is important in particular to provideaccountability for maintaining accurate records of the total usage ofthe patient treatment unit 100, and to track and improve treatmentefficacy. The elapsed treatment timer display, which measures the timeelapsed each time the treatment mode is engaged and then disengaged,which usually represents a portion of the treatment session at aspecific location of the body, resets to zero before a new treatment isinitiated. The elapsed treatment timer display restarts each time a newtreatment is initiated. A manual reset button (not shown) can beprovided to manually reset the elapsed treatment timer on demand; or theelapsed treatment timer display can be configured to automatically resetwhen the probes 103, 105 begin to deliver energy again through the body.

According to one example, the treatment time display 208 is anelectronic timer display that is configured to display an elapsed timein decimal numbers in minute and second format. Alternately, the timercan be expressed visually in manner that readily conveys to the operatorhow much time has elapsed in a time quantity familiar to the operator.For example, a meter graphic or a dial graphic showing elapsed time canbe displayed instead of decimal numbers. The timer displays herein aredifferent from the AEC codes described above in that they areunderstandable by a layperson. While hexadecimal numbers areunderstandable to persons familiar with computer arts, for example, theyare not familiar to the unskilled layperson. It is important for theoperator to see in real time as energy is being provided through theprobes how much time has elapsed. The elapsed time starts from eachactivation of the probe stimulus generator circuit 101 and runs until acorresponding deactivation of the probe stimulus generator circuit 101.A treatment visit by a particular patient can be viewed as a treatmentduration or session following which at least 60 minutes or more elapsebefore the next application of energy to the patient's body. Thetreatment duration can include many applications of energy to the bodyat the same or different locations, but there is a short period of timebetween non-application of energy until the next application of energyon the body (e.g., enough time for the operator to move one or bothprobes to a new location). When more than 60 minutes have elapsed sincethe last application of energy, the treatment visit is concluded as ofthe last application of energy on the body. Because the treatment timeswhen using the aspects of present disclosure are so much shortercompared to treatment times when using prior art treatment approaches,having a human-readable timer displaying the amount of time that haselapsed since the application of energy on the body is important to theoperator. Over-treatment can be counter-productive and produce areduction in efficacy or no material improvement in the reduction ofpain. A contiguous, uninterrupted delivery of electrical energy throughthe body via the conductors is referred to herein as a treatment cycle.A treatment session can comprise multiple treatment cycles, such as whenthe conductors are moved one or more times. A treatment visit for agiven patient can include multiple treatment sessions (which in turn caninclude one or more treatment cycles), but ends when more than 60minutes has elapsed since the last application of electrical energythrough that patient's body.

Referring to FIG. 2B, the primary probe 103 is coupled to the casing ofthe patient treatment unit 100 with a respective cable and is pluggedinto a primary probe socket located on a side of the casing. The primaryprobe 103 has a treatment switch 233 and a probe intensity dial (orwheel) 234, according to one exemplary embodiment. The treatment switch233 is a binary treatment switch that when pushed towards a probe tip235 places the patient treatment unit 100 into a treatment mode.Optionally, the probe tip 235 is rounded. Conversely, when the treatmentswitch 233 is pushed away from the probe tip 235 places the patienttreatment unit 100 into a measurement mode. The intensity dial 234increases a current intensity when dialed (or rotated) toward the probetip 235, and reduces the current intensity when dialed away from theprobe tip 235.

In an alternative exemplary embodiment, which functions consistent withthe present disclosure of the patient treatment unit 100, the treatmentswitch 233 is eliminated entirely, with the probe intensity dial 234being replaced with a similar-looking dial but one that actually tripsinto a locked (off) position when dialed all the way away from the probetip 235. This alternative probe intensity dial effectively performs thefunctions of both the treatment switch 233 and the above-described probeintensity dial 234. When dialed all the way away from the probe tip 235,the alternative probe intensity dial is positioned into a “locked” offposition and the measurement mode is engaged. When the alternative probeintensity dial is dialed toward the probe tip 235 and moved out of itsinitial “locked” position, the treatment mode is turned on, and, as thealternative probe intensity dial is continued to be dialed toward theprobe tip 235, current intensity increases. A benefit of the alternativeprobe intensity is that it provides a simpler, more efficient manner toswitch between the measurement mode and the treatment mode.

In other words, the probe intensity dial 234 is a manual setting forincreasing the variable supply voltage to a desired variable treatmentvoltage. The probe intensity dial 234 is in the form of a detent wheel,according to one exemplary embodiment. The detent wheel 234 is rotatabletowards the

Referring to FIG. 2C, the secondary probe 105 has a respective probe tip236, but lacks a switch or dial. The secondary probe 105 is coupled tothe casing of the patient treatment unit 100 with a respective cable andis plugged into a secondary probe socket located on a side of thecasing.

Referring to FIGS. 3A-3D, the primary probe 103 includes a treatmentswitch 333 that, when in a back position as shown in FIG. 3A, reads therelative conductivity between primary probe 103 and secondary probe 105in a “measurement” mode. In the measurement mode, a small amplitudecurrent is applied between the probes 103 and 105 to measure theimpedance of the tissue to be examined. Voltage and current may besensed and measured periodically, and impedance readings are calculatedperiodically. In measurement mode, the treatment switch 333 activates aconductance (or contact) level display 212 in FIG. 2A to provide avisual indication of the conductivity and impedance of the tissue underexamination. When pushed forward as shown in FIG. 3B, the treatmentswitch 333 activates treatment by completing the sense circuit 117 thatenables the probe stimulus generator circuit 101 to generate anelectrical pulse train output to treat the tissue under examination.When switched to treatment mode, the probe stimulus generator circuit101 receives a handshake signal from the mode control circuit 115. Inthis manner, probe stimulus generator circuit 101 provides outputvoltage to the probes 103 and 105 in the form of the electrical pulsetrain when the mode control circuit 115 enables the handshake signal.

The probe stimulus generator circuit 101 also checks the power supplycircuit 121 to ensure that proper power is provided prior to enablingoutput current in the form of an electrical pulse train. If the power isnot adequate, or if the mode control circuit 115 does not shake hands,the stimulus generator 101 is prevented from outputting the electricalpulse train. The various handshake checks are made by a handshakecontroller. When the patient treatment unit 100 is in measurement mode,the impedance between the probes (and therefore the impedance of thetissue under examination) is shown in the conductance level display 212in FIG. 2A. The LED indication in the conductance level display 212 inFIG. 2A remains on during the measurement modes. Additionally, theprimary probe 103 includes an intensity dial 344 shown in FIG. 3B thatcontrols the intensity of treatment. At the onset of treatment, theintensity dial 344 is turned toward the back of the probe at its minimumsetting as shown in FIG. 3B. The intensity dial 344 is then turnedforward toward the front of the probe 103 as shown in FIGS. 3C and 3Duntil the patient feels the carrier current, but is not uncomfortable.

The mode control circuit 115 detects and tracks an elapsed treatmenttime indicative of the time the primary probe 103 is delivering thesequence of electrical pulses. The mode control circuit 115 is used tomeasure and track treatments for regulatory and payment compliance, toensure patient safety, and for other health or business reasons. Avisual indication of the treatment is presented on the primary timerdisplay and on the secondary timer display, in accordance with theapplicable disclosure presented above.

Patient compliance with treatment is a medical concern regardless of theform of treatment. Patients must follow through with the prescribedtreatments to ensure efficacy and to facilitate recovery. If a patientavoids treatment or takes part in the treatment in a manner notprescribed, the patient's noncompliance masks any effects of thetreatment. This leads to great uncertainty as to the effectiveness ofthe prescribed therapy and whether the current level of treatment isappropriate, or if it is in need of adjustment or discontinuation.Patients are often unwilling to admit they are non-compliant, and when atreatment is difficult or painful, patients may choose to forgo or avoidthe treatment despite proven therapeutic benefits. Misuse of thetreatment weakens the economic and therapeutic incentives for healthcare providers and insurance companies to fund or cover the costs of thetreatment.

After the treatment switch 333 is activated and treatment begins, themode control circuit 115 will start the timer which will be visible inthe display, and the display will visually track the timed elapsed viaminutes and seconds elapsed. The display will continue to count as longas the primary probe 103 remains in treatment mode. Once the treatmentswitch 333 is deactivated (that is, the patient treatment unit isreturned to the measurement mode), the applicable display will stopincrementing but will remain visible. The display will reset to zero andbegin to show elapsed time when the treatment switch 333 on primaryprobe 103 is once again moved forward to re-start additional treatment.At that time, the display will again continue to increment. Instead ofminutes and seconds in decimal numbers, the display can display a bar orline graph, circle graphic, hourglass or sand timer graphic, a clockgraphic, or similar graphic to indicate how much time in a manner thatconveys to a layperson has elapsed since the start of the treatment. Theidea here is not to obfuscate or confound the layperson, but to clearlyconvey to a layperson clinician or caregiver the elapsed time so thatthe caregiver can track the number of minutes and optionally secondshave elapsed since the start of the application of energy in a treatmentmode of the patient treatment unit.

Referring back to FIG. 1, the optional sense circuit 117 is an optionthat evaluates the presence of a probe connection and enables the probestimulus generator circuit 101 when the probes 103, 105 are connected tothe body impedance analysis circuit 107. The sense circuit 117 ensuresthat no electrical pulse train is generated when the probes 103, 105 arenot properly connected. The wall wart power supply 119 and the powersupply circuit 121 provide a stable and regulated 12 volt DC powersource to the patient treatment unit 100. The stable and regulated powersource helps provide an electrical pulse train free from ambientelectrical noise.

The response level circuit 131 measures and indicates the conductivityor impedance between the probes 103 and 105. The intensity adjustmentcircuit 129 is used to adjust the intensity of the electrical pulses.The intensity of the electrical pulses can be varied or changed byadjusting the current using the intensity dial 344 shown in FIG. 3D.

The intensity adjustment circuit 129 is further configured to controlthe variable supply voltage, including setting the variable supplyvoltage to a predefined starting voltage upon activation of the probestimulus generator circuit 101. The predefined starting voltage isgenerally a low voltage selected to avoid an initial painful reaction by(or “zapping” of) a patient. After an initial contact occurs between theprobes 103, 105 and the body, the predefined starting voltage is changedto a variable treatment voltage as required by each individual, customapplication. Thus, after activation of the probe stimulus generatorcircuit 101, the predefined starting voltage is subsequently increasedas treatment proceeds to the treatment voltage, which can vary over thecourse of the treatment. The increase in current is achieved manually(such as via the probe intensity dial 234) or automatically.

Referring to FIG. 4, an exemplary pulse forming circuit 400 isolates thehigh voltage for the probes 103 and 105 that may be included in theprobe stimulus generator circuit 101. The pulse forming circuit 400isolates high voltage from the lower voltage control circuits to producea cleaner waveform with better pulse shape free of ringing. Theresulting unipolar waveform output promotes a unidirectional ionic flow,creating a better net effect. The pulse forming circuit 400 includes ahigh voltage generator 402, a high voltage output circuit 404 and a lowvoltage output control circuit 406.

The high voltage generator 402 includes a step up transformer 410, a setof MOSFETs 412 and 414 and a D flip flop 416. A center tap input 418 iscoupled to a control MOSFET 420 that is coupled to a DC voltage sourcesuch as the power supply circuit 121. A higher clock frequency allows asmaller transformer to be used. The output voltage from the high voltagegenerator 402 is a function of the center tap voltage coupled to thecontrol MOSFET 420 and the turns ratio of the transformer windings(primary to secondary turns).

The low voltage output control circuit includes an inverter 444, ANDgates 446 and 448, and output MOSFETs 450 and 452. The other input ofthe AND gates 446 and 448 are driven by a pulse width modulation controlsignal from a control input 442. The pulse width control signal willtime how long the output pulse is and at what frequency it is applied.The electrical output specifications are as described above in referenceto the parameters of the treatment unit. Additionally, exemplary outputwaveforms of the patient treatment unit 100 and other optional featuresare illustrated in U.S. Pat. No. 10,085,670, issued on Oct. 2, 2018,titled “Apparatus And Method For Treatment Of Pain With Body ImpedanceAnalyzer,” which is incorporated herein by reference in its entirety.

Referring to FIGS. 5A-5C, a method is directed to reducing oreliminating pain using the patient treatment unit 100. As illustrated inFIG. 5A, the patient treatment unit is initially prepared at step 500.The device is turned on at step 502, and a frequency band is selected,ensuring that an intensity wheel on a primary probe is in an off state.A patient characterizes at step 504 the location and severity of thepain. In response to the patient's input, the sensitivity is set at step506 to an appropriate setting, the probes are placed on a treatmentlocation, and a baseline calibration is adjusted. If a conductance levelreading of 7 is not achieved at step 508, then sensitivity is adjustedat step 510 to achieve the conductance level reading of 7.

Referring to FIG. 5B, if the conductance level reading of 7 is achieved,the method proceeds to “1B” by rotating at step 512 an intensity wheelon the primary probe to turn on. This means that the treatment mode isnow engaged. At step 514, the method continues to rotate the intensitywheel on the primary probe to increase or otherwise adjust the intensityof electrical current. If the patient indicates at step 516 that theintensity is not too strong, the afflicted area is treated for 3 minutesat step 518. If the patient indicates at step 516 that the intensity istoo strong, the intensity of current is decreased at step 528 until thepatient is comfortable. The intensity wheel is rotated on the primaryprobe at step 520 until it clocks off. The treatment mode is now off andthe measurement mode is now engaged.

At step 522, if the conductance level reading measured is not 3 lightshigher than before, then at step 526 the same location is treated forone more minute at a pressure within the operating conductor pressurerange disclosed herein. The intensity wheel on the primary probe isrotated until it clicks off to engage the measurement mode again. If theconductance level reading still shows that it is not 3 lights higherthan before, at step 522, the same location is treated again at step526. At step 522, if the conductance level reading is 3 lights higherthan before, a determination is made at step 524 whether the patientindicates that pain is markedly less. If the answer is no, treatment ofthe same location is again treated for one minute at step 526. If theanswer is yes, then the method continues (as illustrated in FIG. 5C) todetermine if there is another treatment location for the patient'scondition.

Referring to FIG. 5C, a determination is made at step 530 if there isanother treatment location for the patient's condition. If the answer isyes, at step 536 the primary and secondary probes are moved to the nexttreatment location and the method repeats generally the stepsillustrated and discussed above in reference to element Z on FIG. 5B. Ifthere is no other treatment location for the patient's condition, atstep 532 the patient's pain is checked when engaged in movement (ifappropriate). If the patient does not have any substantive pain, at step540 the treatment is stopped. If the patient does have substantive painand it is determined that the patient would not benefit from additionaltreatment, as determined at step 538, the treatment is stopped. If thepatient does have substantive pain and it is determined that the patientwould benefit from additional treatment, as determined at step 538, themethod continues at step 536 with another treatment location and themethod repeats generally the steps illustrated and discussed above inreference to element Z on FIG. 5B.

As mentioned above, the treatment modalities disclosed herein can beapplied to treat wounds, including chronic wounds such as cuts,punctures, and ulcers, diabetic wounds, non-healing surgical wounds, andpuncture wounds. These modalities can be coupled with negative pressurewound therapy (NPWT), compression dressings, and/or topical medications.The methods and treatment devices herein have been used to treatdiabetic foot ulcers, pressure ulcers, and venous stasis ulcers. Onechronic wound patient who suffered from chronic pain for years washealed within weeks using the treatment modalities disclosed hereinafter enduring years of non-healing.

Treatment Examples

According to an exemplary treatment, two probes are held and kept aboutone to two inches apart, depending on the size of the person, andmaintained on the body at a pressure within the operating conductorpressure range disclosed herein. The probes are held in-line and next toeach other, and are moved up and down sometimes in unison along aspecific treated area while keeping the pressure within the operatingconductor pressure range. For example, if the treatment is directed to atendon, the probes are held in-line with the tendon and moved straightup and down in unison following the line of the tendon. The probes arelined-up with edges of the tendon, with the electrical current appliedbetween the edges.

In accordance with a specific tendon example, a tendon that isunderneath a kneecap is followed such that same equidistance ismaintained for each probe relative to a respective tendon edge as theprobes are moved in unison up and down for about three to four minutes,with the probes being in-line with each other. Continuous, slow movementup and down along (not across) fibers of the tendon has shown greaterresults than side-to-side movement along or across the tendon whilemaintaining the pressure on the probes within the operating conductorpressure range disclosed herein.

In accordance with another specific tendon example, the Achilles' tendonof the ankle is generally smaller than the patella tendon of the knee.Thus, the two probes cannot be positioned similar to the examplediscussed above. In the case of the Achilles' tendon the probes areplaced in a vertical fashion (e.g., about 90 degrees or orthogonal fromthe surface of the skin) approximately one to two inches away from eachother. They are then moved slowly along the length of the tendon forthree to four minutes at a pressure within the operating conductorpressure range disclosed herein. This technique is also effective intreating pain along the peroneus longus tendon (also known as thefibularis longus) and the posterior tibialis tendon. Both of thesetendons are quite small and thus the vertical placement of the probesallows for constant contact of the tendon throughout the treatment. Insome cases, there may be one area of significant pain along any one ofthese tendons. This small area can be addressed by holding the secondaryprobe stationary about an inch away from it and then moving the primaryprobe superiorly/inferiorly and medially/laterally directly over thissmall area for about one to two minutes at a pressure within theoperating conductor pressure range disclosed herein.

According to another treatment example, a treatment area of a lumbarspine (e.g., L4/L5 or S1/S2) is related to sciatica. The probes are heldstationary at the spine at a pressure within the operating conductorpressure range disclosed herein and are moved together in unison downthe muscle of the spine into the piriformis muscle. Nerves from thespine are enervated from the same nerve line, rebooting the nerve. Thus,the treatment wakes up the nerve and reboots it through treatment of themuscle.

According to yet another treatment example, the treatment area is anelbow and the treatment is directed to an ulnar nerve entrapment orulnaritis. A groove is formed in the nerve inside the elbow, withassociated numbness to in half of the hand's 3rd digit, the 4th digit,and the 5th digit. The probes are taken and gullied where the ulnarnerve sits. The probes are held in the gully for about one minute at apressure within the operating conductor pressure range disclosed herein,then run down to the wrist or finger. A similar approach is applied whentreating pain associated with carpel tunnel.

Generally, treatment is customized based on the specific part treated.For example, as discussed above, treatment of nerves (which act similarto guitar strings) is different than treatment of muscles (which arepliable and can be more easily felt). When treating nerves, probes aremoved over a tunnel and right over nerves while maintaining a pressureon the probes within the operating conductor pressure range disclosedherein. Additionally, treatment of ligaments requires smaller or finermovements of the probes, while treatment of muscles or nerves requiresbigger or gross movements. During treatment, the skin turns white and,then, red based on influx of blood circulation. According to oneexample, the treatment focuses on nickel-sized areas to see where theblood is flowing.

The treatment examples above are in stark contrast to prior treatmentmethods, which typically place stationary pads for 5-30 minutes at onespot, after which the stationary pads are removed and the treatment isterminated. These pads also do not provide a pressure on the skin withinthe operating conductor pressure range disclosed herein.

According to another treatment example, an inflammation is treated bymoving the probes toward the heart. For example, if treating a kneeinflammation, the leg of the patient is elevated and the probes arepositioned around the knee joint. The slow, continuous movement of theprobes starts below where the inflammation (or swelling) is located. Theprobes are positioned on either side of the knee joint and are moved uptoward the patient's hip (toward the heart). The movement is slow andmeticulous around the joint. The distance between the probes is kept atabout one to one-and-a-half inches apart.

The angle of attack, or positioning, of the probes relative to thetreated body part is relevant and changes based on the type of body partthat is being treated. For example, perpendicular positioning of theprobes is beneficial when treating joints. By way of specific example,when movement is around a finger, knee, should, or hip, the probes arepositioned perpendicular to the respective joints and with really goodcontact between the probes and the joints. Otherwise, concentration ofelectrical current is minimized if the probes are angled away from aperpendicular orientation relative to the joint being treated. Similarperpendicularity is beneficial when treatment involves nerves.

When treating muscles, the probes are angled closer to 45 degreesrelative to the muscles being treated. The movement of the probes goesaround the muscles to capture all angles of the muscle to treat a muscletrigger point.

Pressure applied by the probes while energy is being appliedtherethrough should be within the operating conductor pressure rangedisclosed herein, such that skin indentation is generally achieved. Theapplied pressure should be confidently firm, the patient should feel it,but not be pained by it, keeping in mind the probe tips are small,rounded hemispheres. When reaching a trigger point, more pressure isapplied (e.g., at a hip or a piriformis muscle). However, when movementis over a ligament or generally bony area, less pressure is applied toavoid or reduce discomfort.

Typically, the applied current between probes is moved across theproblem area (not along the problem). For example, when treating chronicneck or back pain (e.g., stenosis or arthritis) the probes arepositioned on either side of the spine and holding the pattern ondifferent levels for one to two minutes. In another example, the probesare moved front to back on shoulders or on hips. In contrast, whentreating a knee, the movement is along the side of the knee, treatingthe front and back of the knee separately.

Treatment results show that nerves, tendons, and muscles show greatimprovement in physical condition (e.g., reducing pain associating withsciatic tendons). Surprising beneficial results are achieved, forexample, in treating sciatica in elderly patients. Other surprisingbeneficial results are associated with treatment of ankles, which show agreat reduction in required treatments, e.g., patients that required 15treatments with prior methods now require only 3-8 treatments with thetreatment unit and methods disclosed herein. Yet other surprisingbeneficial results are associated with treatment of nerves, tendons, andmuscles. Tendon treatment, in particular, provides a “wow” factorresult. After treatment of tendons, some patients cancel pre-scheduledsurgery. Thus, tendon treatment is extremely effective.

Knowing the anatomy and nuances for that anatomy is helpful in providingthe appropriate movements of the probes when treating specific bodyparts. The movement of the probes, as discussed above, is helpful ifperformed in a certain way that is beneficial for and is customized tothe part being treated. Thus, precise, individual treatment for aparticular condition and patient is beneficial when appropriate movementis performed with the independently movable probes. In certainapplication, a stationary technique may work, individually or inconjunction with the moving technique.

Case Studies on Human Patients

A number of specific patient treatments are described below in whichelectrical characteristics are the same for each patient. All patientswere treated using DC pulsed current at 20,000 Hertz, with fullintensity on each patient. All patients were alert, awake, not sedated,and in a seating or prone position during treatments. No other painalleviating or conscious-state altering therapies such as painmedication were used during any of these non-drug, non-opioidtreatments. The probe pressure was within the operating conductorpressure range disclosed herein. The outcomes are great improvementscompared to outcomes of previous methods, e.g., (a) more patientsreceived pain relief and (b) more pain relief is achieved by eachpatient. As a whole, the patients averaged 3.6 treatments each, witheach treatment achieving an average of 72% of pain relief for eachsingle treatment. 99% of the patients achieved 70% or better of painrelief over the full course of the treatments. These results are a greatimprovement when compared to the clinical research described above, inwhich patients averaged 7.8 treatments each, each treatment achieved anaverage of 52% pain relief for each single treatment, and 41% achieved70% or better pain relief over the full course of treatment. Thus, thedata below illustrates that the outcomes of the present treatment methodis a great improvement over previous treatment methods, with the numberof required treatments being reduced in half. Additionally, the timerequired for each treatment has decreased on average by about 30-50%.The letter initials below refer to a distinct, real human patient onwhich the following treatments were conducted. While many other realhuman patients were tested, these actual treatments are summarized belowas exemplars of different treatment modalities to treat differentpatient complaints with different resulting therapy improvements andbenefits.

LS—This patient had R Achilles tendinitis. Patient LS had seen a doctorand was going to have a surgical debridement of the tendon. For thispatient, the probes were held for 4 minutes at the insertion site on thecalcaneus while maintaining probe pressure on the skin within theoperating conductor pressure range disclosed herein. The probes werethen moved superiorly along the tendon, holding the tips perpendicularto the tendon. The proves were slowly moved up the tendon for 2 minutes.Then, the most swollen, tender spot, was located. The secondary probewas held stationary and the primary probe was moved up and down in-linewith the tendon at a pressure within the operating conductor pressurerange disclosed herein. The primary probe was moved side to side toprovide cross friction motion across the tendon. The last spot treatedwas the tendon insertion into the gastrocnemius. This spot was held thisspot for 4 minutes at a pressure within the operating conductor pressurerange disclosed herein. This patient had seven treatments. Beforetreatments began, pain was a 9 on a scale of 0-10 (0 being no pain and10 being highest level of pain), and when treatments ended pain waszero. 100% pain reduction, which would not have been achievable withprior approaches.

JH—This patient had lateral knee pain making squatting painful. Atrigger point was found in the vastus lateralis and the probes were heldfor 2 minutes at a pressure within the operating conductor pressurerange disclosed herein. Then, the probes were placed side to side andslowly worked the probes along the vastus lateralis muscle following thelength of the muscle from origin to insertion. This patient had fourtreatments. Before treatments began, pain was a 5 on a scale of 0-10 (0being no pain and 10 being highest level of pain), and when treatmentsended pain was zero. 100% pain reduction.

MM—This patient had peroneal longus tendinitis and Achilles tendinitis.The treatment was started at the origin of the peroneus longus and theprobes were held for 2 minutes at a pressure within the operatingconductor pressure range disclosed herein. The probes were then lined-upand moved along the length of the peroneus longus and brevis. The probeswere moved slow for 4 minutes at a pressure within the operatingconductor pressure range disclosed herein. The primary probe was movedwhile the secondary probe was kept stationary when the lateral malleoluswas reached. This technique was used all the way to the insertion at the5th metarsal. This patient had two treatments. Before treatments began,pain was a 6 on a scale of 0-10 (0 being no pain and 10 being highestlevel of pain), and when treatments ended pain was zero. 100% painreduction.

JOH—This patient had acute onset of shin splints the day before whilerunning. The trigger point was found at the posterior tibialis and theprobes were kept on this spot for 2 minutes at a pressure within theoperating conductor pressure range disclosed herein. The probes weremoved slowly down the length of the posterior tibial tendon to the archof the foot for a total of 4 minutes at a pressure within the operatingconductor pressure range disclosed herein. This patient had twotreatments. Before treatments began, pain was an 8 on a scale of 0-10 (0being no pain and 10 being highest level of pain), and when treatmentsended pain was zero. 100% pain reduction.

BM—This was a post-op knee re-alignment patient. He had significant kneepain and swelling. The probe tips were kept perpendicular to the leg,started at the calf, and slowly moved the probes towards the heart,keeping the probes side to side about 1.5 inches apart while maintaininga pressure on the probes within the operating conductor pressure rangedisclosed herein. This was done for about 4 minutes, working the entireknee. Then, the probes were held at the top of the gastrocnemius muscleand above the knee (posterior) near the medial and lateral femoralcondyles. This patient had eleven treatments. Before treatments began,pain was a 9 on a scale of 0-10 (0 being no pain and 10 being highestlevel of pain), and when treatments ended pain was zero. 100% painreduction.

MG—This was a patient suffering from R sciatica. The right side ofL3/L4/L5/S1 was treated. Then, L4/L5 was traced, moving probes slowly,to the gluteus medius trigger point and held there for 2 minutes at apressure within the operating conductor pressure range disclosed herein.The probes were then moved back to L4/L5/S1 and, then, slowly moved topiriformis. The probes were held at the piriformis trigger point for 2minutes, then were slowly moved down to ischial tuberosity. The probeswere held there for 2 minutes, then moved for 2 minutes medially andlaterally for 2 minutes at a pressure within the operating conductorpressure range disclosed herein. The proves were then moved down thehamstring slowly (2 minutes total) and kept on the trigger point inbiceps femoris for 2 minutes at a pressure within the operatingconductor pressure range disclosed herein. This patient had sixtreatments. Before treatments began, pain was an 8 on a scale of 0-10 (0being no pain and 10 being highest level of pain), and when treatmentsended pain was zero. 100% pain reduction.

EB—This patient had thumb pain along the extensor pollicis brevis andabductor pollicis longus tendons. The secondary probe was held still andthe primary probe was moved along these tendons for 2 minutes each at apressure within the operating conductor pressure range disclosed herein.The tendons are too small to run both probes along the tendons. Theprobes were held stationary for 2 minutes at the CMC joint and at wristjoint at a pressure within the operating conductor pressure rangedisclosed herein. The patient had only one treatment. Before treatmentsbegan, the patient had pain that was a 6 on a scale of 0-10 (0 being nopain and 10 being highest level of pain), and when treatments ended thepain was zero. 100% pain reduction.

OH—This patient was a soccer player with pain along peroneal tendons andcalf pain. The trigger points were found at the peroneus longus andbrevis. The probes were held there for 2 minutes each at a pressurewithin the operating conductor pressure range disclosed herein. Then,the probes were lined up along the peroneal tendons and were moved alongthe entire length around the lateral malleolus to the insertion at thebase of the 5th metatarsal. This movement was for a total of 4 minutes.This patient had two treatments. Before treatments began, pain was a 6on a scale of 0-10 (0 being no pain and 10 being highest level of pain),and when treatments ended pain was zero. 100% pain reduction.

JW—This male patient had R hip flexor strain. This was a college andsemi-pro soccer player. The treatment was started at the R ASIS, andwere held there for 2 minutes at a pressure within the operatingconductor pressure range disclosed herein. The rectus femoris triggerpoint was found, and the patient's leg was gently extended over the sideof the treatment table. Then, the probes were lined-up side to side, andslowly moved down to the knee. This was also performed on the Sartoriusmuscle and tendon, but here the patient bent his knee and externallyrotated his hip. This patient had one treatment. Before treatmentsbegan, pain was a 5 on a scale of 0-10 (0 being no pain and 10 beinghighest level of pain), and when treatments ended pain was zero. 100%pain reduction.

JW—This female patient was a 40 year-old runner that had had pain for 9months and had been to two chiropractors. She could not run, but wastrying to train for a marathon. The patient had pain in left buttocks.The treatment was started at L5 and the probes were held there for 2minutes at a pressure within the operating conductor pressure rangedisclosed herein. Then, the probes were moved to S1 for 2 minutes, andthen to S2 for 2 minutes. From S2, the probes were moved slowly alongthe piriformis from the sacrum to the greater trochanter of the femur.The probes were moved slowly for about 4 minutes. The trigger point wasfound in the piriformis and were kept there for 2 minutes at a pressurewithin the operating conductor pressure range disclosed herein. Thispatient had one treatment. Before treatments began, the pain was an 8 ona scale of 0-10 (0 being no pain and 10 being highest level of pain),and when treatments ended pain was zero. 100% pain reduction.

JB—This patient had cervical radiculopathy. The symptoms were that of aC7 radiculopathy. The patient experienced pain back at upper arm andwrist, numbness and tingling in back of arm and middle finger of theright hand. The probes were held at C5/C6/C7/C8 for 2 minutes each.Then, the probes were placed on either side of C6 and C7 for 1 minuteeach. The probes were moved slowly from C6 down the neck to UT, held for2 minutes, then to levator scapulae and held for 2 minutes at a pressurewithin the operating conductor pressure range disclosed herein. Theprobes were then moved slowly to infraspinatus, down the deltoid, to thetriceps, and finally at wrist extensors. This treatment took about 8minutes. This patient had five treatments. Before treatments began, painwas a 9 on a scale of 0-10 (0 being no pain and 10 being highest levelof pain), and when treatments ended pain was zero. 100% pain reduction.

FB—This patient had lumbar radiculopathy with symptoms that were atL4/L5. The probes were held probes at these levels to the right of thespine for 2 minutes, then on either side for 1 minute at a pressurewithin the operating conductor pressure range disclosed herein. Thesymptoms were also felt into buttocks and leg. The probes were moved totrace from the spinal segments to the glut medius, then to piriformis,to hamstring, and then peroneals. The treatment took about 10 minutes.Movement was slow while pressure on the probes was maintained within theoperating conductor pressure range disclosed herein. This patient hadone treatment. Before treatments began, pain was a 10 on a scale of 0-10(0 being no pain and 10 being highest level of pain), and whentreatments ended pain was a 2. 80% pain reduction.

While various embodiments of the present disclosure have been describedabove, it should be understood that they have been presented by way ofexample only, and not limitation. Numerous changes to the disclosedembodiments can be made in accordance with the disclosure herein,without departing from the spirit or scope of the disclosure. Thus, thebreadth and scope of the present disclosure should not be limited by anyof the above described embodiments. Rather, the scope of the disclosureshould be defined in accordance with the following claims and theirequivalents.

The terminology used herein is for the purpose of describing particularembodiments only, and is not intended to be limiting of the invention.As used herein, the singular forms “a,” “an,” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. Furthermore, to the extent that the terms “including,”“includes,” “having,” “has,” “with,” or variants thereof, are used ineither the detailed description and/or the claims, such terms areintended to be inclusive in a manner similar to the term “comprising.”

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art. Furthermore, terms, such as those definedin commonly used dictionaries, should be interpreted as having a meaningthat is consistent with their meaning in the context of the relevantart, and will not be interpreted in an idealized or overly formal senseunless expressly so defined herein.

1-20. (canceled)
 21. A method of supplying electrical energy to treatpain or inflammation or a wound in a patient to reduce or treat the painor inflammation or wound, comprising the steps of: initiating a firsttreatment cycle, the initiating including: arranging a plurality ofconductors at a plurality of locations onto living tissue of a body of ahuman or animal in an area where pain or inflammation or wound isindicated, a first conductor of the plurality of conductors having anelectrically conductive tip, each of the plurality of conductors beingelectrically coupled to a device having a timer, causing electricalenergy to be conducted via at least the first conductor and into thetissue in the form of a treatment signal supplied by the device, thetreatment signal including a pulse train of direct current (DC) pulseshaving a pulse frequency in a range between 18 and 22 kiloHertz (kHz), apulse current from 0.1 milliAmperes (mA) to 6.0 mA, and a pulse voltagedependent on a variable supply voltage supplied to the probe stimulusgenerator circuit and providing a maximum pulse voltage of about 165Volts of DC (VDC); based on a first elapsed time counted by the timer,ceasing or pausing delivery of the treatment signal supplied by thedevice to terminate the first treatment cycle; initiating a secondtreatment cycle, the second treatment cycle including: causing thetreatment to be conducted via at least a second conductor of theplurality of conductors and into the area or a different area of thetissue; based on a second elapsed time counted by the timer, ceasing orpausing delivery of the treatment signal supplied by the device toterminate the second treatment cycle.
 22. The method of claim 21,further comprising, during the first treatment cycle and the secondtreatment cycle, causing a pressure between 0.05 to 10 pounds to beapplied to the first conductor and the second conductor while thetreatment signal is being supplied by the device.
 23. The method ofclaim 21, wherein the second treatment cycle lasts a shorter durationrelative to the first treatment cycle.
 24. The method of claim 21,wherein the first treatment cycle further includes monitoring animpedance or conductivity of the body and responsive to observing nochange therein during the first treatment cycle, maintaining the firstconductor at the same location in the second treatment cycle.
 25. Themethod of claim 21, wherein the first conductor is positioned at anangle that is relatively orthogonal to the body so that the treatmentsignal has a component that passes from the first conductor into thebody at the angle.
 26. The method of claim 21, further comprising:during the first treatment cycle, moving or lifting the first conductorfrom the first location and placing the first conductor at a newlocation onto the body and applying firm pressure between 0.05 to 10pounds at the new location to at least one of the first conductor or thesecond conductor; and holding the first conductor stationary during atleast part of the second treatment cycle while maintaining the firmpressure on the first conductor.
 27. The method of claim 21, used totreat pain, or inflammation, or a wound in the human or animal, whereinthe wound includes a diabetic wound, an ulcer, an infection, a cut, oran incision wound.
 28. The method of claim 21, wherein the firstconductor or the second conductor is arranged on a pad.
 29. The methodof claim 21, wherein the surface of the body corresponds to a finger, aknee, a shoulder, a hip, a joint, or a nerve on the body.
 30. A methodof supplying electrical energy to treat pain or inflammation or a woundin a patient to reduce or treat the pain or inflammation or wound,comprising the steps of: causing electrical energy in the form of anelectroceutical treatment signal supplied by a device to be selectivelyapplied to changing locations via a plurality of conductors contactingliving tissue of a body of a human or animal in an area where pain orinflammation or would is indicated, the electroceutical treatment signalincluding a pulse train of direct current (DC) pulses having a pulsefrequency in a range between 18 and 22 kiloHertz (kHz), a pulse currentfrom 0.1 milliAmperes (mA) to 6.0 mA, and a pulse voltage dependent on avariable supply voltage supplied to the probe stimulus generator circuitand providing a maximum pulse voltage of about 165 Volts of DC (VDC),the plurality of conductors being electrically coupled to the device;and based on a timer of the device, ceasing or suspending delivery ofthe electrical energy as a current location of the plurality oflocations is changed to a new location to cause the electroceuticaltreatment signal to be delivered to the new location on the body thatdiffers from the current location.
 31. The method of claim 30, furthercomprising causing a pressure between 0.05 to 10 pounds to be applied tothose or that one of the plurality of conductors that are involved indelivering the treatment signal to the body.
 32. The method of claim 30,wherein one or more of the plurality of conductors is/are positioned atan angle that is relatively orthogonal to the body so that theelectroceutical treatment signal has a component that passes from eachof the plurality of conductors into the body at the angle.
 33. Themethod of claim 30, wherein at least one of the conductors involved indelivering the electroceutical treatment signal to the body ismaintained at a stationary position relative to the body as theelectrical energy is conducted between the body and the device.
 34. Themethod of claim 30, wherein at least one of the conductors has anelectrically conductive tip that is rounded.
 35. The method of claim 30,wherein the changing locations treat a muscle trigger point on the body.36. The method of claim 30, used to treat pain, or inflammation, or awound in the human or animal, wherein the wound includes a diabeticwound, an ulcer, an infection, a cut, or an incision wound, wherein thepain includes pain associated with tendinitis, tendon, tissue, knee,shin splints, sciatica, calf, hip, piriformis, arm, shoulder, wrist,ligament, finger, hand, or spine, and wherein the inflammation includesswelling or edema.
 37. The method of claim 30, wherein the changinglocations are confined to an area no greater than a nickel.
 38. Themethod of claim 30, wherein the changing locations corresponding to amovement to follow the pain as indicated by the patient.
 39. The methodof claim 30, further comprising: prior to causing the electrical energyto be selectively applied to changing locations, initiating a treatmentsession; and stopping delivery of the electroceutical treatment signalresponsive to changing the locations at least twice to end the treatmentsession.
 40. The method of claim 30, further comprising monitoring animpedance or conductivity of the body and responsive to a reduction inthe impedance or conductivity changing the location on the body ofdelivery of the electroceutical treatment signal.